Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
Lot numbers, UPCs & expiration codes
Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0622-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 25, 2019
- FDA report date
- Dec 25, 2019
- Quantity
- 640,325 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medisca, Inc.
Original FDA data
Every field from FDA enforcement report D-0622-2020, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 84357
- Address
- 661 State Route 3 Unit C
- Code information
- Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L
- Postal code
- 12901-6531
- Report date
- Dec 25, 2019
- Product type
- Drugs
- Recall number
- D-0622-2020
- Classification
- Class II
- Recalling firm
- Medisca, Inc.
- Product quantity
- 640,325 grams
- Termination date
- Mar 17, 2021
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2019